Inflatable off-loading wound dressing assemblies, systems, and methods

ABSTRACT

To offload forces from a tissue site being treated with reduced pressure, an offloading pressure component may be used as part of a reduced-pressure treatment system. A reduced-pressure source of the reduced-pressure treatment system vents positive pressure exhaust into the offloading pressure component to inflate the offloading pressure component. The offloading pressure component disperses forces away from the tissue site. Other devices, methods, and systems are presented.

RELATED APPLICATIONS

The present invention claims the benefit, under 35 USC §119(e), of thefiling of U.S. Provisional Patent Application Ser. No. 61/365,614,entitled “Inflatable Off-loading Wound Dressing Assemblies, Systems, andMethods,” filed 19 Jul. 2010, which is incorporated herein by referencefor all purposes [VAC.0965PRO]; U.S. Provisional Patent Application Ser.No. 61/407,194, entitled “System and Methods For Electrically DetectingThe Presence of Exudate In Reduced-Pressure Dressings,” filed 27 Oct.2010, which is incorporated herein by reference for all purposes[VAC.0975PRO1]; and U.S. Provisional Patent Application Ser. No.61/418,730, entitled “Systems and Methods for Electrically Detecting thePresence of Exudate in Dressings,” filed 1 Dec. 2010, which isincorporated herein by reference for all purposes [VAC.0975PRO2].

FIELD

The disclosure relates generally to reduced-pressure medical treatmentsystems and more particularly, but not by way of limitation, toinflatable off-loading wound dressing assemblies, systems, and methods.

BACKGROUND

Clinical studies and practice have shown that providing a reducedpressure in proximity to a tissue site augments and accelerates thegrowth of new tissue at the tissue site. The applications of thisphenomenon are numerous, but one particular application of reducedpressure involves treating wounds. This treatment (frequently referredto in the medical community as “negative pressure wound therapy,”“reduced-pressure therapy,” or “vacuum therapy”) provides a number ofbenefits, including migration of epithelial and subcutaneous tissues,improved blood flow, and micro-deformation of tissue at the wound site.Together these benefits result in increased development of granulationtissue and faster healing times. Typically, reduced pressure is appliedby a reduced-pressure source to tissue through a porous pad or othermanifold device. In many instances, wound exudate and other liquids fromthe tissue site are collected within a canister to prevent the liquidsfrom reaching the reduced-pressure source. At times, the tissue sitebeing treated is at a pressure point on the patient, e.g., on the backof a bed-ridden patient.

SUMMARY

In one illustrative embodiment, a reduced-pressure treatment system forapplying reduced pressure treatment to a tissue site includes a woundcover for covering the tissue site and forming a sealed space andincludes a reduced-pressure source that provides reduced pressure to thetissue site and provides a positive pressure exhaust. Thereduced-pressure treatment system further includes an offloadingpressure component for dispersing positive pressure exerted on or nearthe tissue site. The offloading pressure component is fluidly coupled tothe reduced-pressure source for receiving at least a portion of thepositive pressure exhaust.

According to another illustrative embodiment, a system for treating atissue site with reduced pressure includes a reduced-pressure sourcethat produces reduced pressure and a positive pressure exhaust andincludes an offloading pressure component. The offloading pressurecomponent has a deflated state and an inflated state. The offloadingpressure component includes at least one flexible wall forming an innerspace of the offloading pressure component. The inner space is fluidlycoupled to the reduced-pressure source and is operable to receive thepositive pressure exhaust generated by the reduced-pressure source.

In yet another illustrative embodiment, a method for offloading pressureexerted proximate to a tissue site to which reduced pressure is appliedincludes applying a wound cover over the tissue site. The method furtherincludes applying reduced pressure to the tissue site using areduced-pressure source coupled to the wound cover. The method furtherincludes inflating an inner space of an offloading pressure componentcoupled to the reduced-pressure source. The offloading pressurecomponent is operable to disperse positive pressure exerted proximate tothe tissue site.

Other features and advantages of the illustrative embodiments willbecome apparent with reference to the drawings and detailed descriptionthat follow.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic, cross-sectional side view of a reduced-pressuretreatment system having an offloading pressure component according to anillustrative embodiment shown in a deflated state;

FIG. 2 is a schematic, cross-sectional side view of the reduced-pressuretreatment system of FIG. 1 in which the offloading pressure component isin an inflated state according to an illustrative embodiment;

FIG. 3 is a schematic, top view of a reduced-pressure treatment systemhaving an offloading pressure component according to anotherillustrative embodiment;

FIG. 4 is a schematic, cross-sectional view of the offloading pressurecomponent of FIG. 3 taken along line 4-4; and

FIG. 5 is a schematic, cross-sectional view of an illustrativeembodiment of a reduced-pressure treatment system shown with an inflatedoffloading pressure component dispersing a force exerted by a patient'sweight; and

FIG. 6 is a schematic, exploded, perspective view of thereduced-pressure treatment system of FIG. 5.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

In the following detailed description of several illustrativeembodiments, reference is made to the accompanying drawings that form apart hereof, and in which is shown by way of illustration specificpreferred embodiments in which the invention may be practiced. Theseembodiments are described in sufficient detail to enable those skilledin the art to practice the invention, and it is understood that otherembodiments may be utilized and that logical structural, mechanical,electrical, and chemical changes may be made without departing from thespirit or scope of the invention. To avoid detail not necessary toenable those skilled in the art to practice the embodiments describedherein, the description may omit certain information known to thoseskilled in the art. The following detailed description is, therefore,not to be taken in a limiting sense, and the scope of the illustrativeembodiments are defined only by the appended claims.

Referring to the drawings and initially and primarily to FIG. 1, across-sectional side view of a reduced-pressure treatment system 100according to an illustrative embodiment is presented. Thereduced-pressure treatment system 100 is applied to a tissue site 110,such as a wound. The tissue site may be a wound or defect located on orwithin any tissue, including but not limited to, bone tissue, adiposetissue, muscle tissue, neural tissue, dermal tissue, vascular tissue,connective tissue, cartilage, tendons, or ligaments. The tissue site mayfurther refer to areas of any tissue that are not necessarily wounded ordefective, but are instead areas in which it is desired to add orpromote the growth of additional tissue. For example, reduced pressuretissue treatment may be used in certain tissue areas to grow additionaltissue that may be harvested and transplanted to another tissuelocation.

The reduced-pressure treatment system 100 includes a dressing assembly102 and a reduced-pressure source 180, which may be integral to orseparate from the dressing assembly 102. The dressing assembly 102 ofthe illustrative embodiment of FIG. 1 includes a cover 140, thereduced-pressure source 180 coupled to or incorporated into the cover140 for providing reduced pressure treatment to the tissue site 110, andan absorbent layer 130 for absorbing exudates and other liquids drawnfrom the tissue site 110. The reduced-pressure treatment system 100includes an offloading pressure component 170 for dispersing positivepressure exerted on or near the tissue site 110. The offloading pressurecomponent 170 may, for example, allow a patient to lay on their backeven though the tissue site being treated is on their back because theoffloading pressure component 170 offloads or prevents a substantialload from being placed on the tissue site 110. The offloading pressurecomponent 170 is an inflatable bladder or inflatable and deflatablebladder.

In addition, in certain embodiments, the reduced-pressure treatmentsystem 100 may include an onboard control unit 164, an internal powersource, such as a battery 162, and one or more sensors (not shown), suchas, but not limited to, a pressure sensor for monitoring a pressurelevel exerted by the reduced-pressure source 180 on the tissue site 110,or for monitoring a pressure level within the offloading pressurecomponent 170. As used herein “or” does not require mutual exclusivity.The one or more sensors may provide pressure readings to the onboardcontrol unit 164 or an external reduced-pressure treatment unit forenabling the onboard control unit 164 to adjust the operations of thereduced-pressure treatment system 100.

The cover 140, or drape, may be made of a flexible material that coversthe tissue site 110 to protect the tissue site 110 from the externalenvironment and forms or helps form a fluid seal. The cover 140 mayextend beyond a perimeter of the tissue site 110 and may include anadhesive, bonding agent, or other attachment device on a peripheralportion of the cover 140 to secure the cover 140 to tissue adjacent tothe tissue site 110. The cover 140 may be used to create a sealed space141 over the tissue site 110. The adhesive disposed on the cover 140 maybe used to form a fluid seal between the tissue and the cover 140 toprevent leakage of reduced pressure from the tissue site 110.

The absorbent layer 130 is disposed beneath (for the orientation shown)the cover 140 and is used to absorb exudates and other liquids drawnfrom the tissue site 110. The absorbent layer 130 may be integrated withthe cover 140 or the absorbent layer 130 may be a separate component ofthe reduced-pressure treatment system 100. The absorbent layer 130 maybe made from any material capable of absorbing liquid, such as exudate,from the tissue site 110. In one illustrative embodiment, the absorbentlayer 130 is made from a super absorbent fiber. The super absorbentfibers may hold onto or bond to the liquid in conjunction with aphysical or chemical change to the fibers. In one illustrative,non-limiting example, the super absorbent fiber may include the SuperAbsorbent Fiber (SAF) material from Technical Absorbents®, Ltd. In someembodiments, the absorbent layer 130 may include an odor adsorptionmaterial (not shown) such as, but not limited to, activated charcoal forreducing or eliminating the odor associated with the collected exudates.

The reduced-pressure treatment system 100 may also include a treatmentmanifold 120 adapted to be positioned proximate to the tissue site 110.The treatment manifold 120 may be partially or fully in contact with thetissue site 110 that is being treated by the reduced-pressure treatmentsystem 100. When the tissue site 110 is a wound, the treatment manifold120 may partially or fully fill the wound bed. The treatment manifold120 may be any size, shape, or thickness depending on a variety offactors, such as the type of treatment being implemented or the natureand size of the tissue site 110. For example, the size and shape of thetreatment manifold 120 may be customized by a user to cover a particularportion of the tissue site 110, or to fill or partially fill the tissuesite 110. The treatment manifold 120 may have, for example, a squareshape, or may be shaped as a circle, oval, polygon, an irregular shape,or any other shape.

The treatment manifold 120 is a material, e.g., a foam material, thatdistributes reduced pressure to the tissue site 110 when the treatmentmanifold 120 is in contact with or near the tissue site 110. The foammaterial may be either hydrophobic or hydrophilic. In one illustrative,non-limiting example, the treatment manifold 120 is an open-cell,reticulated polyurethane foam, such as GranuFoam®. dressing availablefrom Kinetic Concepts, Inc. of San Antonio, Tex.

In the example in which the treatment manifold 120 is made from ahydrophilic material, the treatment manifold 120 also functions to wickfluid away from the tissue site 110, while continuing to provide reducedpressure to the tissue site 110 as a manifold. The wicking properties ofthe treatment manifold 120 draw fluid away from the tissue site 110 bycapillary flow or other wicking mechanisms. An example of a hydrophilicfoam is a polyvinyl alcohol, open-cell foam, such as V.A.C. WhiteFoam®dressing available from Kinetic Concepts, Inc. of San Antonio, Tex.Other hydrophilic foams may include those made from polyether. Otherfoams that may exhibit hydrophilic characteristics include hydrophobicfoams that have been treated or coated to provide hydrophilicity.

The treatment manifold 120 may be constructed from bioresorbablematerials that do not have to be removed from a patient's body followinguse of the reduced-pressure dressing assembly 102. Suitablebioresorbable materials may include, without limitation, a polymericblend of polylactic acid (PLA) and polyglycolic acid (PGA). Thepolymeric blend may also include, without limitation, polycarbonates,polyfumarates, and capralactones. The treatment manifold 120 may furtherserve as a scaffold for new cell-growth, or a scaffold material may beused in conjunction with the treatment manifold 120 to promotecell-growth. A scaffold is a substance or structure used to enhance orpromote the growth of cells or formation of tissue, such as athree-dimensional porous structure that provides a template for cellgrowth. Illustrative examples of scaffold materials include calciumphosphate, collagen, PLA/PGA, coral hydroxy apatites, carbonates, orprocessed allograft materials.

In the illustrative embodiment of FIG. 1, reduced pressure is applied tothe tissue site 110 by the reduced-pressure source 180. In oneembodiment, the reduced-pressure source 180 is a micropump 191 that maybe, for example, an electrically-driven vacuum pump and in otherembodiments may be a non-motor driven pump. In still other illustrativeembodiments, the reduced-pressure source 180 may be remote but fluidlycoupled to the dressing assembly 102. In such embodiments, a dual lumenconduit may be used with one lumen delivering reduced pressure to thetissue site and one lumen delivering positive pressure to the inflatableportions, e.g., the offloading pressure component 170.

The micropump 191 may be a micropump that is small and light enough thatthe cover 140 is able to be maintained on the tissue site 110 with themicropump 191 included. Furthermore, the size and weight of themicropump 191 should be such that the cover 140 does not pull orotherwise adversely affect the tissue site 110. In one embodiment, themicropump 191 may be a disk pump having a piezoelectric actuator. Inthis and other non-motor-driven pump embodiments, the pump used togenerate reduced pressure is not driven by an electric motor or othermotor. In the case of the piezoelectric pump, the pump generates fluidflow by supplying an electric current to a piezoelectric actuator. Thepiezoelectric actuator vibrates when supplied with electric current, andthese vibrations are used to generate a pressure differential within apump cavity (relative to the ambient environment of the pump). Thepiezoelectric actuator may be positioned directly adjacent to the pumpcavity such that the vibration of the actuator is directly transformedinto pressure waves within the pump cavity, or alternatively thepiezoelectric actuator may be positioned adjacent a diaphragm thattransmits the vibrations of the piezoelectric actuator to the pumpcavity. In an alternative embodiment, the micropump 191 may be aperistaltic pump that is used for pumping a variety of fluids. It shouldbe understood that alternative pump technologies may also be utilizedand that rotary, linear, or other configurations of pumps may beutilized. In still another embodiment, reduced pressure may be suppliedfrom a location remote from the cover 140.

In another illustrative embodiment, the reduced-pressure source 180 mayinstead be a manually-actuated or manually-charged pump that does notrequire electrical power. In one embodiment, the reduced-pressure source180 may be integrated as part of the cover 140. The reduced-pressuresource 180 supplies reduced pressure to the tissue site 110 and drawsexudates and other liquids from the tissue site 110, through thetreatment manifold 120 and into the absorbent layer 130.

Reduced pressure generally refers to a pressure less than the ambientpressure at a tissue site that is being subjected to treatment. In mostcases, this reduced pressure will be less than the atmospheric pressureat which the patient is located. Alternatively, the reduced pressure maybe less than a hydrostatic pressure associated with tissue at the tissuesite 110. Reduced pressure may initially generate fluid flow in the areaof the tissue site 110. As the hydrostatic pressure around the tissuesite 110 approaches the desired reduced pressure, the flow may subside,and the reduced pressure is then maintained. Unless otherwise indicated,values of pressure stated herein are gauge pressures. Similarly,references to increases in reduced pressure typically refer to adecrease in absolute pressure, while decreases in reduced pressuretypically refer to an increase in absolute pressure.

In the illustrative embodiment of FIG. 1, the reduced-pressure source180 includes an exhaust port 190 for exhausting gas (positive pressureexhaust) generated during operation of the reduced-pressure source 180.The gas exhausted through the exhaust port 190 is used to inflate theoffloading pressure component 170, which may comprise an inflatablebladder. In some embodiments, the reduced-pressure source 180 mayinclude an exhaust valve 188 for controlling or limiting the flow of thegas exhausted by the reduced-pressure source 180. For instance, in oneembodiment, the exhaust valve 188 is operable to control or limitexhaust gas flow through either an exhaust port path 181 leading out ofexhaust port 190 to the inflatable device 170 or to an atmosphericexhaust path 183 that directs the gas exhausted from thereduced-pressure source 180 to enter the surrounding atmosphere or bedelivered to another location. While not explicitly shown, theatmospheric exhaust path 183 may include an odor filter, e.g., acharcoal filter (see, e.g., charcoal filter 244 in FIG. 6). The flow maybe continuous or intermittent.

For example, the exhaust valve 188, or positive-pressure valve, may beconfigured to exhaust all or a portion of the gas through theatmospheric exhaust path 183 if the offloading pressure component 170 isto remain in a deflated or a semi-deflated state or is already inflated.In one embodiment, the operation of the exhaust valve 188 may becontrolled automatically by the onboard control unit 164 or by anexternal control unit. For example, the onboard control unit 164 maystore a set of preconfigured parameters, such as, but not limited to,the desired pressure, frequency of inflation, and the duration ofinflation. In addition, or in lieu of, in some embodiments, theoperation of the exhaust valve 188 may be manually controlled by acaregiver or a patient by either manually toggling a switch or by thepush of a button on a control unit.

In one illustrative embodiment, the positive pressure exhaust from thereduced-pressure source 180 is delivered to the exhaust valve 188 at aninlet. The valve may contain a pressure regulator that provides a safetyoverpressure release. In other words, if the pressure experienced by theoverpressure release is beyond a threshold, the overpressure releasewill allow fluid to exit. Downstream of the overpressure release may bea (1) manual input valve for bleeding or directing all or a portion ofthe positive pressure to atmosphere 183 or (2) an automated input thatwill release positive pressure beyond a threshold.

In addition, in some embodiments, the reduced-pressure source 180 mayinclude a reduced-pressure valve 189, or purge valve, disposed adjacentto a gas inlet 184 of the reduced-pressure source 180. Thereduced-pressure valve 189 may be used to redirect, control, or limitthe flow of reduced pressure to either an atmospheric reduced-pressurepath 185 for receiving airflow from the surrounding atmosphere, or to atissue site reduced-pressure path 187 for providing reduced pressure tothe tissue site 110. For example, in one embodiment, thereduced-pressure source 180 is operable to draw air from the surroundingatmosphere using the reduced-pressure valve 189, and exhaust the drawnair through the exhaust port 190 to quickly inflate the offloadingpressure component 170. Alternatively, or in addition to, in someembodiments, the reduced-pressure source 180 is operable to draw airfrom the surrounding atmosphere, in conjunction with simultaneouslyproviding reduced pressure to the tissue site 110, for inflating theoffloading pressure component 170, such as when the reduced pressurebeing applied to the tissue site 110 is insufficient to produce enoughexhaust for inflating the offloading pressure component 170 by itself oras quickly as desired.

In one embodiment, a liquid-air separator (not shown) is positionedbetween the absorbent layer 130 and the gas inlet 184 that preventsliquid from entering the reduced-pressure source 180 and allows gas(e.g., reduced pressure) to be communicated for maintaining reducedpressure at the tissue site 110. The liquid-air separator may be ahydrophobic or oleophobic filter that prevents passage of liquids, butallows gaseous communication. Examples of a suitable hydrophobicmaterial include an expanded PTFE laminate, such as a hydrophobicmedical membrane manufactured by WL Gore & Associates, Newark, Del. Inone illustrative embodiment, the PTFE laminate may be a laminate and mayhave a 1.0 micron reference pore size on non-woven polyester with athickness range of 0.0068 mm-0.0135 min. An example of a suitableoleophobic material includes an oleophobic expanded ptfe membrane havinga 1.0 micron reference pore size on non-woven polyester with a thicknessrange of 0.15 mm-0.39 mm. The oleophobic membrane may have a minimum airflow of 12 LPM/cm2/bar (15 PSI) and a minimum water entry pressure of0.8 bar (12.0 PSI). Alternatively, the substantially planar liquid-airseparator may be a gravity-based barrier system, or a device thatincludes a hydrophilic surface to encourage condensation or otherseparation of liquid from a fluid stream when the fluid stream passesover the surface. Other examples of the liquid-air separator may includesintered metals, sintered nylons, or any other material or device thatis capable of separating liquid from a fluid stream, or that isotherwise capable of substantially preventing the passage of liquidwhile allowing the passage of gases.

With reference now primarily to FIGS. 1-2, in accordance with adisclosed illustrative embodiment, the offloading pressure component 170is coupled to the cover 140 and the reduced-pressure source 180, and isoperable to receive the exhaust port 190 of the reduced-pressure source180 through an aperture 178 (FIG. 4) of the offloading pressurecomponent 170. As described above, in one embodiment, positive pressureexhaust generated during operation of the reduced-pressure source 180exits through the exhaust port 190 and into an inner space 202 of theoffloading pressure component 170 and inflates the offloading pressurecomponent 170. FIG. 1 shows the offloading pressure component 170 in adeflated state and FIG. 2 shows the offloading pressure component 170 inthe inflated state.

In the depicted embodiment, the offloading pressure component 170includes a relief valve 160 that is operable to release air from theoffloading pressure component 170. In one embodiment, the relief valve160 may be configured to prevent the pressure from exceeding a maximumpredetermined value within the offloading pressure component 170 or maybe used to prevent the offloading pressure component 170 from burstingif too much air or pressure is exerted within the offloading pressurecomponent 170. In one illustrative embodiment, the relief valve 160includes a spring holding the relief valve 160 closed. When the internalpressure exceeds the force of the spring, the relief valve 160 opens andair is released from the offloading pressure component 170 until thepressure drops below the force exerted by the spring. In someembodiments, a user may manually open the relief valve 160 for deflatingthe offloading pressure component 170. Additionally or alternatively,the relief valve 160 may be automatically controlled by the onboardcontrol unit 164 or by an external control unit for maintaining adesired pressure or state within the offloading pressure component 170.

In one illustrative embodiment, the offloading pressure component 170forms an annular or donut shape. An interior region of the donut shaped,offloading pressure component 170 may substantially encompass the tissuesite 110 for enabling the inflated offloading pressure component 170 tooffload pressure to the external boundaries or beyond of the tissue site110. The offloading pressure component 170 may be circular, oval,square, triangular, or any other desired shape that best conforms to thesize and shape of the tissue site 110.

Referring now primarily to FIG. 3-4, another illustrative embodiment ofthe offloading pressure component 170 is presented. This embodimentillustrates the offloading pressure component 170 having a rectangularshape in plan view. The embodiment is shown in a deflated state in FIG.3. FIG. 4 presents the offloading pressure component 170 of FIG. 3 as across section in an inflated state. The cross section of the offloadingpressure component 170 shows a concave pillow shape to the offloadingpressure component 170. The reduced-pressure source 180 is illustratedbeneath (for the orientation shown) the offloading pressure component170. The offloading pressure component 170 includes an aperture 178(shown in FIG. 4) that is in fluid communication with the exhaust port190 of the reduced-pressure source 180. In some embodiments, a sealingring 192, such as an O-ring, is seated between the exhaust port 190 ofthe reduced-pressure source 180 and the aperture 178 of the offloadingpressure component 170. The sealing ring 192 is operable to maintain aseal that enables gaseous communication between the exhaust port 190 andthe aperture 178 of the offloading pressure component 170.

In one illustrative embodiment, the sealing ring 192 may be coupled toboth the exhaust port 190 and the offloading pressure component 170 formaintaining a fluid seal. The coupling may be made by any technique,e.g., welding (ultrasonic or RF or other weld), bonding, adhesives, orcements. As another approach to coupling, the bottom layer 176 of theoffloading pressure component 170, which may be formed from atransparent material, may be melted with a laser to the sealing ring192. In another illustrative embodiment, the bottom layer 176 of theoffloading pressure component 170 is coupled to the sealing ring 192 andthen top layer 174 is coupled to the bottom layer 176.

In another illustrative embodiment, the offloading pressure component170 may be formed with an inflatable spigot (not shown) that engages thesealing ring 192. The inflatable spigot, which may receive positivepressure exhaust from the reduced-pressure source 180, is like a shaftin an o-ring. As the inflatable spigot inflates or experiences moreinternal pressure, the strength of the seal between the spigot andsealing ring 192 increases. In still another illustrative embodiment,the top layer 174 of the offloading pressure component 170 is formedfrom a material not affected by heat from ultrasonic welding and thebottom layer 176 is formed from a material that is affected by heat fromultrasonic welding. The offloading pressure component 170 may placedadjacent to the sealing ring 192 with the bottom layer 176 adjacent tothe sealing ring 192 and then exposed to the ultrasonic welding process.Thus, the sealing ring 192 is coupled to the bottom layer 176.

In the depicted embodiment of FIG. 3, the reduced-pressure source 180includes electrical lead lines 194 for receiving power from an externalpower source 200. In one embodiment, the reduced-pressure source 180 mayalso include data lines 196 for communicating data signals between thereduced-pressure source 180 and an external control unit 210. Theexternal control unit 210 may contain sensors, processing units, alarmindicators, memory, databases, software, display units, and a userinterface that further facilitate the application of reduced pressuretreatment to the tissue site 110. In one example, a sensor or switch(not shown) may be disposed at or near the reduced-pressure source 180to determine a source pressure generated by the reduced-pressure source180 or a pressure within the offloading pressure component 170. Thesensor may communicate with a processing unit in the external controlunit 210 that monitors and controls the reduced pressure that isdelivered by the reduced-pressure source 180 or the pressure within theoffloading pressure component 170. In one embodiment, an alarm may betriggered in response to the pressure exceeding a threshold, such as,but not limited to, a maximum pressure threshold or a minimum pressurethreshold.

Referring primarily to FIG. 4, in one embodiment, the offloadingpressure component 170 comprises a top layer 174 (or first layer) and abottom layer 176 (or second layer). The top layer 174 and the bottomlayer 176 may be made of any type of flexible film material such as, butnot limited to, plastic or rubber. In some embodiments, the top layer174 and the bottom layer 176 may be made of different materials. The toplayer 174 and the bottom layer 176 may be coupled together by anysuitable means, such as, but not limited to, welding or adhesivelybonding the two layers together, or formed as an integral member. Forexample, FIGS. 3 and 4 depict weld lines 172 that connect the top layer174 and the bottom layer 176 together. The top layer 174 and the bottomlayer 176 form the inner space 202 that is operable to receive air froman exhaust port 190 through an aperture 178 located on the bottom layer176. The top layer 174 may be formed with a concave area that is overthe tissue site being treated.

Although FIG. 4 depicts an embodiment comprising of two layers, inalternative embodiments, the offloading pressure component 170 maycomprise any number of layers. For example, in one embodiment, theoffloading pressure component 170 may comprise a single layer that issealed directly to the cover 140 to create the inner space 202 betweenthe single layer and the cover 140. In other embodiments, the offloadingpressure component 170 may comprise more than two layers. For example,in one embodiment, the offloading pressure component 170 may havemultiple layers between the top layer 174 and the bottom layer 176 forcreating a stack of cushioned air within the inner space 202, or acushion within a cushion.

Referring now primarily to FIGS. 5-6, another illustrative embodiment ofa reduced pressure treatment system 100 with a dressing assembly 102 ispresented. The reduced pressure treatment system 100 includes anoffloading pressure component 170. In FIG. 5, which shows the offloadingpressure component 170 in the inflated state, the weight or force 220 ofa patient's body or body part is being supported by a surface 222, suchas a bed. The offloading pressure component 170, or inflatable cushion,includes an inflatable bladder 224. With respect to a free body diagram,the weight or force 220 exerted by the patient is supported by the force226 that is normal to and outboard of the tissue site 110 being treated.The distributed force 226 counters the force 220 without directlyapplying force onto the tissue site 110 itself.

The offloading pressure component 170 is shown as an inflatable annularmember having the inflatable bladder 224. A central portion 225 mayinterface with the pump 180 to receive positive pressure exhaust from anoutlet port 190. A charcoal filter 244 may be placed between the outletport 190 and an inlet or aperture 178 of the offloading pressurecomponent 170.

The reduced-pressure dressing assembly 102 includes a treatment manifold120, or interface layer, adapted to be positioned at the tissue site110, and a seal layer 231 to seal the reduced-pressure dressing assembly102 around the tissue site 110. A first manifold layer 232 is positionedin fluid communication with the treatment manifold 120 to distribute thereduced pressure to the treatment manifold 120 and the tissue site 110.An absorbent layer 130 is positioned in fluid communication with thefirst manifold layer 232 to absorb liquid from at least one of the firstmanifold layer 232, the treatment manifold 120, and the tissue site 110.A diverter layer 234, which may contain one or more apertures 246, maybe positioned adjacent to the absorbent layer 130. A second manifoldlayer 236 may be positioned in fluid communication with the diverterlayer 234, and a liquid-air separator 238 may be positioned adjacent thesecond manifold layer 236. A cover 140, or drape, is positioned adjacentto the second liquid-air separator 238. An odor filter or odor-treatingmaterial may also be positioned within the reduced-pressure dressingassembly 102.

In addition to the layers of the reduced-pressure dressing assembly 102listed above, the reduced-pressure dressing assembly 102 includes a pump180 that may be integrated into the reduced-pressure dressing assembly102 between the liquid-air separator 238 and the cover 140. The pump 180may be a micropump that is small and light enough such that thereduced-pressure dressing assembly 102 (including the micropump) is ableto be maintained on the tissue site 110.

The pump 180 may be disposed within the reduced-pressure dressingassembly 102 to avoid conduits and external canisters for collection ofwound exudate. The pump 180 includes the outlet port 190. The outletport 190 is in fluid communication with an aperture 240 in the cover140. A sealing ring 192, e.g., and O-ring or seal, may be used to form afluid seal with the outlet port 190 or to couple the offloading pressurecomponent 170 and the reduced-pressure dressing assembly 102.Alternatively, the cover 140 may be sealed around an outlet port of thepump 180 such that gas from the pump 180 is able to exhaust directlythrough the aperture 240. In the embodiment illustrated in FIGS. 5-6,the outlet port 190 of the pump 180 is oriented in a direction away fromthe hydrophobic filter to avoid adding air under the cover 140 and toallow the air to enter the inflatable component 170, or cushion. The airexhausts through the aperture 240 in the cover 140, which may include aone-way valve. Alternatively, the air or other gas could be exhaustedthrough a gas-permeable portion of the cover 140.

When a piezoelectric-driven pump is used as the pump 180 in the dressingassembly 102, the piezoelectric actuator associated with the pump 180may, at times, be driven at different frequencies to act as a buzzer orvibrating alert system. The alert system may be used to alert a user toan alarm condition such as the presence of a leak in the cover 140, achange in reduced pressure as measured by a sensor, an indication thatthe dressing assembly 102 has absorbed a maximum capacity of liquid asmay be indicated by an indicator, or an indication that one or morelayers are no longer manifolding reduced pressure efficiently.

Control electronics, or control unit 210, may be utilized to controloperation of the pump 180. The control unit 210 may be analog or digitaland be configured with a regulator (not shown) to regulate speed or dutycycle at which the pump 180 operates. Furthermore, the control unit 210may be configured with a controller (not shown) that receives sensesignals from sensors or switches (not shown). The sensors may bedisposed throughout the reduced-pressure dressing assembly 102 to senseparameters, such as pressure, temperature, moisture, chemistry, odor, orany other parameter that may be utilized in managing and controlling thepump 180. In one embodiment, the control unit 210 includes a computerprocessor. Alternatively, the control unit 210 may include aprogrammable gate array. The control unit 210 may also be formed usinganalog electronic components. It should be understood that the controlunit 210 may include any form of digital or analog components to performfunctionality as described herein.

Four parameters are often of concern when performing reduced pressurewound treatment: (i) low pressure, (ii) excessive leak, (iii) level ofabsorbent layer, and (iv) battery state. The control unit 210 mayinclude electronics that may be utilized to monitor each of the fourparameters and generate an alarm signal (e.g., high-pitched beep,vibration, or light) using a speaker (not shown), vibrator (not shown),or illumination device (not shown), such as a light emitting diode(LED), to notify a medical professional, patient, or family member thata parameter is outside of a safe range. For example, if a pressure atthe wound site 110 is below a therapeutic level, a continuous tone maybe generated. As another example, if the absorbent layer 130 issaturated, then continuous beeps may be generated. If the battery dropsbelow a certain voltage level, then a different frequency may begenerated or LED may be turned on. A variety of different alarm signalsmay be established to notify a medical professional or the patient totake a particular action.

An internal power source, e.g., a battery 162, may be utilized toprovide electric power to the pump 180 and the control unit 210. Thebattery 162 may have any size and shape configuration and be housed inany material, such as polymer, to accommodate weight and size, of thereduced-pressure dressing assembly 102. In one embodiment, the battery162 may be rechargeable. In another embodiment, the battery 162 may bedisposed within or outside of the reduced-pressure dressing assembly 102and be positioned in such a manner as to allow for easy replacement orrecharging. In one embodiment, the battery 162 may be configured with avoltage level sensor (not shown) that is monitored by the control unit210 for determination of a low power level. In one embodiment, thebattery 162 may be directly connected with the pump 180. Alternatively,the battery 162 may be connected to the control unit 210 that may usepower from the battery 162 to drive the pump 180. The control unit 210may provide continuous power, modulated power, such as a pulsewidthmodulated (PWM) signal, to drive the pump 180.

The seal layer 231 may be adhered to or otherwise connected to the cover140. The seal layer 231 may include an aggressive or medical gradeadhesive material that is strong enough to form a vacuum seal with skinaround a wound of a patient. The seal layer 231 may be a band that hasan opening 242.

In another embodiment, the seal layer 231 may be adhered to the diverterlayer 234 and the diverter layer 234 adhered to the cover 140 to createan upper (or first) dressing portion and a lower (or second) dressingportion. The upper dressing portion may include the cover 140, the pump180 and related components, the liquid-air separator 238, the secondmanifold layer 236, and the diverter layer 234. The lower dressingportion may include the absorbent layer 130, the first manifold layer232, the seal layer 231, and the treatment manifold 120. In oneembodiment, the reduced-pressure dressing assembly may be configured toallow replacement of the lower dressing portion once the dressing hasabsorbed a maximum capacity of fluid. The upper dressing portion may bereused after the lower dressing portion is replaced. This allowsmultiple use of the pump 180, while disposable portions of the dressingassembly 102 may be replaced. In another embodiment, the pump 180,control unit 210, and battery 162 may be removed from the dressingassembly 102 for reuse and the remaining layers of the dressing assembly102 replaced. In still another embodiment, the absorbent layer 130 onlymay be replaced. In yet another embodiment, the absorbent layer 130 andthe treatment manifold 120 only may be replaced.

The charcoal filter 244 may be utilized in the reduced-pressure dressingassembly 102 to reduce odors created by the tissue site and exhaustedfrom the reduced-pressure dressing assembly 102. The charcoal filter 244may be disposed above a valve or other output vent from the pump 180 tofilter exhaust from the pump 180 prior to being released from thereduced-pressure dressing 102 into the inflatable component 170. Itshould be understood that the charcoal filter 244 may be alternativelyconfigured and disposed above or below the pump 180. In anotherillustrative embodiment, rather than using a charcoal filter or inaddition, charcoal may be integrated into any or all of the differentlayers utilized in the reduced-pressure dressing assembly 102.

In another illustrative embodiment, a method for collecting liquid in adressing assembly positioned at a tissue site includes generating areduced pressure using a pump positioned within the dressing assembly. Aliquid is absorbed from the tissue site and is stored in the dressingassembly. The liquid is prevented from entering the pump. The method mayfurther include maintaining the reduced pressure within the dressing andexhausting gas from the pump into an inflatable component that dispersesforces that would otherwise be applied through the dressing assemblydirectly onto the tissue site.

While the depicted illustrative embodiments illustrate the use of asingle pump and a single offloading pressure component, alternativeembodiments may include any number of pumps and offloading pressurecomponents. The offloading pressure component may be supplied separatelyso as to provide user flexibility as to when and where the offloadingpressure component may be applied.

The disclosed embodiments may be used as part of a process or method foroffloading pressure exerted on or near a tissue site in which reducedpressure is applied to promote healing of the tissue site and forreducing patient discomfort. In one embodiment, the method includesapplying a wound dressing assembly to cover the tissue site, andapplying reduced pressure to the tissue site using a reduced-pressuresource coupled to the wound dressing assembly. The method furtherincludes inflating an inner space of an offloading pressure componentcoupled to the reduced-pressure source. The offloading pressurecomponent is operable to disperse positive pressure exerted on or nearthe tissue site for reducing the exerted pressure to the tissue site.

Although the present invention and its advantages have been disclosed inthe context of certain illustrative embodiments, it should be understoodthat various changes, substitutions, permutations, and alterations canbe made without departing from the scope of the invention as defined bythe appended claims. It will be appreciated that any feature that isdescribed in a connection to any one embodiment may also be applicableto any other embodiment.

It will be understood that the benefits and advantages described abovemay relate to one embodiment or may relate to several embodiments. Itwill further be understood that reference to “an” item refers to one ormore of those items.

The steps of the methods described herein may be carried out in anysuitable order, or simultaneously where appropriate.

Where appropriate, aspects of any of the embodiments described above maybe combined with aspects of any of the other embodiments described toform further examples having comparable or different properties andaddressing the same or different problems.

It will be understood that the above description of preferredembodiments is given by way of example only and that variousmodifications may be made by those skilled in the art. The abovespecification, examples and data provide a complete description of thestructure and use of exemplary embodiments of the invention. Althoughvarious embodiments of the invention have been described above with acertain degree of particularity, or with reference to one or moreindividual embodiments, those skilled in the art could make numerousalterations to the disclosed embodiments without departing from thescope of the claims.

1. A reduced-pressure treatment system for applying reduced-pressuretreatment to a tissue site, the system comprising: a wound cover forcovering the tissue site an for forming a sealed space; areduced-pressure source producing a positive pressure exhaust andreduced pressure, the reduced-pressure source for providing reducedpressure to the tissue site; and an offloading pressure component fordispersing positive pressure exerted on or near the tissue site, theoffloading pressure component fluidly coupled to the reduced-pressuresource for receiving at least a portion of the positive pressureexhaust.
 2. The reduced-pressure treatment system of claim 1, whereinthe offloading pressure component is an inflatable and deflatablebladder.
 3. The reduced-pressure treatment system of claim 1, whereinthe offloading pressure component includes an aperture for coupling anexhaust port of the reduced-pressure source to the offloading pressurecomponent, and wherein the positive pressure exhaust from thereduced-pressure source exits through the exhaust port and into theoffloading pressure component for inflating the offloading pressurecomponent.
 4. The reduced-pressure treatment system of claim 3, furthercomprising an exhaust valve for limiting the flow of gas from theexhaust port into the offloading pressure component.
 5. Thereduced-pressure treatment system of claim 3, further comprising asealing ring operable to maintain a seal between the exhaust port of thereduced-pressure source and the offloading pressure component. 6.(canceled)
 7. The reduced-pressure treatment system of claim 1, whereinthe offloading pressure component includes a relief valve operable torelease air from the offloading pressure component.
 8. Thereduced-pressure treatment system of claim 1, wherein thereduced-pressure source includes a reduced-pressure valve that enablesthe reduced-pressure source to draw atmospheric air into the offloadingpressure component to inflate the offloading pressure component. 9.(canceled)
 10. (canceled)
 11. (canceled)
 12. (canceled)
 13. (canceled)14. (canceled)
 15. The reduced-pressure treatment system of claim 1,wherein the offloading pressure component comprises at least two layersof flexible film welded together.
 16. (canceled)
 17. (canceled) 18.(canceled)
 19. A system for treating a tissue site with reducedpressure, the system comprising: a reduced-pressure source that producesreduced pressure and a positive pressure exhaust; and an offloadingpressure component having a deflated state and an inflated state, theoffloading pressure component comprising at least one flexible wallforming an inner space of the offloading pressure component, the innerspace fluidly coupled to the reduced-pressure source and operable toreceive the positive pressure exhaust generated by the reduced-pressuresource.
 20. The system of claim 19, wherein the inner space is fluidlycoupled to an exhaust port of the reduced-pressure source to receivepositive pressure exhaust.
 21. The system of claim 19, wherein the innerspace is formed by two layers of flexible film welded together.
 22. Thesystem of claim 19, wherein the inner space is formed by two layers offlexible film adhesively bonded together.
 23. The system of claims 21,further comprising: an aperture located on one of the two layers forcoupling an exhaust port of the reduced-pressure source to theoffloading pressure component.
 24. The system of claim claims 21,further comprising: an aperture located on one of the two layers forcoupling an exhaust port of the reduced-pressure source to theoffloading pressure component; and a sealing ring operable to maintain aseal between the exhaust port of the reduced pressure source and theoffloading pressure component.
 25. The system of claim 19, furthercomprising a relief valve operable to release air from the offloadingpressure component.
 26. (canceled)
 27. The system of claim 19, furthercomprising a pressure sensor for determining a pressure within the innerspace.
 28. The system of claim 19, wherein the inner space forms a donutshape.
 29. A method for offloading pressure exerted proximate to atissue site in which reduced pressure is applied, the method comprising:applying a wound cover over the tissue site; applying reduced pressureto the tissue site using a reduced-pressure source coupled to the woundcover; and inflating an inner space of an offloading pressure componentcoupled to the reduced-pressure source, the offloading pressurecomponent operable to disperse positive pressure exerted proximate tothe tissue site.
 30. The method of claim 29, wherein thereduced-pressure source is a micropump.
 31. The method of claim 29,further comprising inflating the inner space of the offloading pressurecomponent using gas generated by the reduced-pressure source.
 32. Themethod of claim 29, further comprising inflating the inner space of theoffloading pressure component using exhaust generated by thereduced-pressure source while the reduced-pressure source is supplyingreduced pressure to the tissue site.
 33. (canceled)
 34. The method ofclaim 29, further comprising limiting inflation of the inner space ofthe offloading pressure component using an exhaust valve.
 35. The methodof claim 29, further comprising: monitoring a pressure within theoffloading pressure component using at least one sensor; and triggeringan alarm in response to the pressure exceeding a threshold. 36.(canceled)
 37. The method of claim 29, further comprising applying asealing ring between an exhaust port of the reduced-pressure source andthe offloading pressure component in order to couple the exhaust port ofthe reduced-pressure source to an inner space of the offloading pressurecomponent.
 38. The method of claim 29, further comprising powering thereduced-pressure source using a power source integrated within the woundcover.
 39. The method of claim 29, further comprising powering thereduced-pressure source using an external power source.
 40. (canceled)41. (canceled)